Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT06571058
Eligibility Criteria:
Inclusion Criteria:
* PATIENT PARTICIPANT: Must be English-speaking
* PATIENT PARTICIPANT: Able to comprehend and agree to consent
* PATIENT PARTICIPANT: Able to read and complete the Acceptability of Implementation Measure (AIM) survey
* PATIENT PARTICIPANT: Be willing to participate using the B3 Buddy device
* PATIENT PARTICIPANT: Have an indwelling urinary catheter or urostomy device connected to a drainage bag
* PATIENT PARTICIPANT: Have no restrictions in ambulation
* CLINICIAN PARTICIPANT: Must be English-speaking
* CLINICIAN PARTICIPANT: Able to comprehend and agree to consent
* CLINICIAN PARTICIPANT: Able to read and complete the System Usability Scale (SUS) survey
* CLINICIAN PARTICIPANT: Be willing to participate using the B3 Buddy device
* CLINICIAN PARTICIPANT: Have a professional role in assisting patients in ambulation in normal workday activities
Exclusion Criteria:
* Those patient participants that have more than one urinary-like drainage bags will be excluded. This exclusion is due to the limited prototype samples available to the research team. Limiting one device for one patient with multiple drainage bags may not allow for accurate assessment of the B3 Buddy device
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT06571058
Study Brief:
Protocol Section:
NCT06571058